‘My Advocacy is Not About Me, My Advocacy is About Canadians’: A Qualitative Study of how Caregivers and Patients Influence Regulation of Medical Assistance in Dying in Canada

Abstract Medical assistance in dying (MAiD) was legalised federally in Canada after the Supreme Court decision in Carter v Canada (Attorney General) [2015] 1 SCR 331. The federal legislative framework for MAiD was established via Bill C-14 in 2016. Caregivers and patients were central to Carter and subsequent litigation and advocacy, which resulted in amendments to the law via Bill C-7 in 2021. Research has primarily focused on the impacts of regulation on caregivers and patients. This qualitative study investigates how caregivers and patients influence law reform and the operation of MAiD practice in Canada (ie, behave as ‘regulatory actors’), using Black’s definition of regulation. We found that caregivers and patients performed sustained, focused, and intentional actions that influenced law reform and the operation of MAiD in practice. Caregivers and patients are not passive objects of Canadian MAiD regulation, and their role in influencing regulation (eg, law reform and MAiD practice) should be supported where this is desired by the person. However, recognising the burdens of engaging in regulatory action to address barriers to accessing MAiD or to quality care, and MAiD system gaps, other regulatory actors (eg, governments) should minimise this burden, particularly where a person engages in regulatory action reluctantly.


I. INTRODUCTION
A. Overview This article focuses on patients' and caregivers' roles in influencing medical assistance in dying (MAiD) regulation in Canada. 1 MAiD is known by other terms around the world, including euthanasia, physician-assisted dying, and voluntary assisted dying.MAiD was legalised in Canada after a 2015 Supreme Court of Canada (SCC) decision found the absolute prohibition on physician-assisted dying was unconstitutional. 2 The subsequent amendment of the Canadian Criminal Code 3 ('Criminal Code') in June 2016 via Bill C-14 established the MAiD legal framework. 4MAiD is defined in section 241.1 of the Criminal Code as the administering of a substance to a person by a medical or nurse practitioner, at the person's request, that causes their death (or prescribing or providing such a substance to a person so that they may self-administer the substance to cause their own death).As of December 31 2022, more than 44 958 people had accessed MAiD in Canada. 5Canada is one of a growing number of jurisdictions permitting MAiD. 6 central rationale for MAiD is respecting autonomy, 7 and caregivers are integral in supporting patients to make choices about MAiD.8 Despite this, caregivers and patients are often conceived of as passive objects (or 'regulatees') 9 of the MAiD system rather than as having an active role in influencing MAiD laws and how MAiD systems operate.For example, existing literature focuses primarily on the impact of laws, policies, and system design on patients' and caregivers' experiences, 10 not their role in influencing their own experiences as well as altering laws, policies, and system design more broadly. N scholarship investigates whether actions of caregivers and patients may constitute regulation (broadly construed) in the Canadian context, though a recent article by Rivest and others has called for further research on involving patients as partners in medical education about MAiD and palliative care.11 This absence in literature is problematic given recognition that patient and family caregiver involvement in influencing healthcare may result in better quality healthcare both for individuals and systems.12 This article challenges passive conceptions of patients' and caregivers' roles as being only objects of MAiD regulation.Using a qualitative, empirical method, we investigate how actions of patients seeking MAiD, and caregivers, may constitute 'regulation' of MAiD in Canada.We seek to answer the question: in what ways, if any, do caregivers and patients behave as regulatory actors in Canadian MAiD systems?As will be elucidated further throughout this article, 'regulation' is a term that has been defined in many ways in regulatory scholarship. Wile it has traditionally been conceptualised as law and formal rules, in healthcare (and other) contexts regulation is increasingly understood to be decentred and polycentric, with a much broader range of individuals and tools that influence behaviour.13 This study adopts prominent regulatory scholar Julia Black's definition of 'regulation' as sustained, focused, and intentional action to alter behaviour to achieve a particular outcome or outcomes.14 Therefore a person who undertakes sustained, focused, and intentional action to alter behaviour is a 'regulatory actor'.
Based on our empirical findings, we argue (i) caregivers and patients behave as 'regulatory actors' in Canadian MAiD systems in a plethora of ways.This means (ii) caregivers and patients should be recognised as actors with voice and agency who can alter Canadian MAiD regulation and are (iii) integral to MAiD law reform and the operation of Canada's MAiD system in practice.Therefore, (iv) other regulatory actors within Canadian MAiD systems (such as governments) should be responsive to their actions, and ensure the burden of having to take regulatory action to address barriers to access, barriers to quality care, or system gaps does not fall unduly on caregivers and patients, particularly those who act  1).For individuals whose natural deaths are reasonably foreseeable, the 'Track 1' safeguards apply (Table 1).
Bill C-7 made other changes to the law in response to advocacy efforts,33 including allowing an exception to the requirement to provide final consent immediately prior to MAiD provision in some cases (Table 1).The latter amendment is often referred to as 'Audrey's Amendment'. 34This reflects the powerful advocacy of Audrey Parker (supported by friends), including a poignant video filmed just prior to her death, advocating for the final consent requirement to be removed. 35Audrey had Stage IV breast cancer and died through MAiD earlier than she wanted for fear of losing the capacity to provide final consent. 36Many other caregivers and patients have advocated for reform too, demonstrated by Dying With Dignity Canada's (DWDC) blog page,37 and testimony before parliamentary committees, including the Special Joint Committee hearings on MAiD. 38aregivers and patients have evidently been instrumental in Canadian MAiD law reform both in terms of litigation39 and wider advocacy: their actions directly contributed to MAiD legalisation through Bill C-14, and they also drove changes implemented by Bill C-7. 40

C. Other sources of Canadian MAiD regulation
The legal framework in the Criminal Code is the foundation of Canadian MAiD regulation.'Regulation' is sometimes traditionally understood to refer to the law made by the state,41 and in the Canadian healthcare context is often used to refer to the activities of formal bodies (ie, 'formal regulators'), such as medical or nursing colleges setting and enforcing standards for behaviour. 42But regulation is increasingly recognised as being broader than this, encompassing a range of sources and actors that influence behaviour, beyond formal sources. 43We use Black's broad definition of regulation: … the sustained and focused attempt to alter the behaviour of others according to defined standards or purposes with the intention of producing a broadly identified outcome or outcomes, which may involve mechanisms of standard-setting, information-gathering and behaviour-modification. 44 Black's definition has three elements: (i) sustained and focused action; (ii) directed towards altering others' behaviour; and (iii) intention to produce a particular outcome. 45lack does not limit regulation based on who is performing the action, whether the action successfully achieves an outcome, or whether a person can enforce that outcome.Instead, this definition focuses on what people are doing and why.Black's definition of regulation is described as a decentred or polycentric account of regulation because it recognises that the state is not the sole source of regulation, and that many different individuals and tools impact regulation. 46ecentred and polycentric definitions of regulation are apposite for healthcare (eg, MAiD) where no single entity has the power and knowledge required to regulate effectively. 47There is clear evidence of non-state actors influencing regulation of MAiD in Canada since its legalisation.For example, regulatory gaps resulting from the federalprovincial MAiD regulatory patchwork (ie, MAiD is regulated by federal criminal law, but also supplementary provincial and territorial health legislation, policy, and other sources) have been filled by non-government individuals and entities.These include the Canadian Association of MAiD Assessors and Providers (CAMAP) (the national professional body, which grew from a need 'to establish training resources, to create medical standards, and to encourage the standardisation of care' 48 and has developed a national clinical MAiD curriculum) 49 ; DWDC (the national peak body representing individual interests relating to MAiD and other end-of-life choices) which plays an important role including by distributing knowledge about MAiD, 50 advocating for improved access, and organising witnesses 51 ; and individual health institutions and practitioners. 52These organisations, while not formal 'regulators' enforcing behaviour through law or formal rules, are arguably 'regulatory actors' who take sustained and focused action, directed towards altering others' behaviour, with the intention of producing particular outcomes.This raises the central question relevant here: can caregivers and patients be regulatory actors too?The role of caregivers and patients in regulating healthcare has scarcely been investigated, 53 and is contested. 54Healy describes that historically patients have, paradoxically, been the 'missing person' in discussions about healthcare regulation. 55Yet, there is clear evidence of caregivers and patients (eg, Kay Carter, Gloria Taylor, Jean Truchon,  Nicole Gladu, Julia Lamb, and Audrey Parker) impacting MAiD law reform in Canada, and therefore influencing regulation.A cognate study investigating this question in an Australian state's assisted dying system also found that some caregivers and patients acted as regulatory actors. 56This article investigates the ways in which caregivers and patients may be seen to behave as regulatory actors in Canada, adopting Black's definition of regulation.

II. METHODOLOGY A. Study design
This study is nested within an international study examining MAiD regulation in Australia, Canada, and Belgium. 57We adopt a critical realist approach. 58This article reports experiences of caregivers and patients in influencing Canadian MAiD regulation, drawing on data collected through qualitative interviews with a patient and caregivers.
Ethics approval was obtained from the Queensland University of Technology University Human Research Ethics Committee (#2000000270) and the Dalhousie University Research Ethics Board (#2020-5313 and #2021-5688).This study is reported according to COREQ guidelines. 59

B. Eligibility and recruitment
Patients were eligible to participate if they had requested MAiD and begun the assessment process, irrespective of the outcome or whether the process was complete.Caregivers were eligible if they had supported a patient through the MAiD process.For feasibility, participants were recruited from three provinces, selected to provide geographic and regulatory diversity (MAiD implementation varies by province and territory): British Columbia, Ontario, and Nova Scotia. 60nitially, we relied on convenience sampling to recruit participants who contacted us in response to recruitment material shared via DWDC mailing lists, our website, and Twitter. 61e also used purposive sampling to ensure diversity, 62 including DWDC contacting individuals with experiences we were seeking (eg, non-cancer diagnoses), and the research team contacting individuals with whom they had pre-existing connections.We also used snowball sampling. 63Recruitment ceased when the research team were satisfied there was sufficient 'information power'. 64

C. Data collection
Data were collected via qualitative, semi-structured interviews.The research team developed interview guides for each cohort (caregivers and patients).Interview guides were similar but contained some different questions, reflecting the different nature of experiences (Supplementary Material).Interviews covered issues relevant to the broader international study, such as about the MAiD request and assessment process.These questions were relevant in answering the question investigated in this article because they provided an overarching picture of the person's MAiD experience.However, prompts were also used to elicit information specifically about potential regulatory action.For example, participants were asked: 'Were there any roadblocks?Disagreements?Difficulties accessing MAiD?What was done to get past this?Prompt (if disagreement or barrier): Explore if they initiated complaint process, formal or informal, and how this was initiated.'Because of our semi-structured approach to interviews, we asked additional questions to clarify and probe areas of interest or complexity raised by participants.
RJ led all interviews, with JD participating in two early interviews (including the patient interview) to test and refine interview guides and ensure appropriateness within the Canadian context.EC participated in a further 11 interviews as part of RJ's research training, to iteratively refine the interview guides, and inform other aspects of the broader Canadian study.One of these 11 interviews was jointly conducted by RJ and EC because the participant had a dual role as a caregiver and healthcare professional, i.e., they had supported a family member to access MAiD, and separate to this experience, they are a MAiD assessor/ provider (relevant to the broader study).Interviews were conducted via Zoom between October 9 2021 and August 5 2022.All participants provided informed consent.All caregiver interviews occurred after the patient who they supported died, so consent from patients was not sought.RJ debriefed after each interview with other members of the research team, and RJ and EC maintained a reflexive journal.

D. Data analysis
Interviews were recorded and professionally transcribed verbatim.Transcripts were sent to participants (member checking). 65Six participants provided supplementary information by email, which was included in the analysis.All transcripts and supplementary information were deidentified and uploaded to NVivo (QSR International, release 1.6.1)for analysis using codebook template analysis (some themes were developed deductively, with inductive and iterative theme refinement). 66ur analysis drew on an analytical framework developed by RJ, EC, LW, and BW in a cognate study from Victoria, Australia. 67RJ initially deductively coded data into four overarching a priori themes: actions, motivations, impacts, and mediating factors.Once these data were identified, RJ inductively coded the data again line by line.A second author (EC) reviewed the subset of data to enrich analysis and iteratively refine the thematic framework, including exploring possible diverse interpretations of the data. 68The four themes reported here mirror the Victorian study.Both surface-level (semantic) and underlying (latent) themes are reported.

A. Overview of results
Thirty-two interviews were conducted with 34 participants between October 2021 and August 2022 (1 patient, 33 caregivers; Table 2) about 33 patient experiences of MAiD (Table 3).Two interviews involved two caregivers (eg, a son and daughter-in-law), and one participant spoke about two patients.All caregivers were supportive of MAiD in principle and of the patient's choice to access MAiD (expressions of supportiveness were sometimes explicit and sometimes implicit).The sole patient interview was conducted with a patient who was in the process of being assessed for MAiD.Interviews ranged between 55 and 203 min, with a median of 83.5 min.
Using the analytical framework developed in the Victorian cognate study, 69 we developed four themes: (i) potentially regulatory actions by caregivers and patients; (ii) motivations for actions; (iii) outcomes of actions; and (iv) mediating factors, which impact on actions, motivations, and outcomes.These themes overlap (Fig. 1).Reflecting this study's focus on regulation (broadly defined), this analysis is focused on patient and family caregiver actions to influence the MAiD system, rather than on efforts to influence the individual healthcare relationship.

B. Theme 1: potentially regulatory actions
Participants (and the patients they described) performed potentially regulatory actions, including: (i) storytelling; (ii) complaints and feedback; (iii) taking on a system role; (iv) organisational involvement; (v) representative and consultancy roles; (vi) resource development; (vii) law reform efforts; and (viii) future activity planned.

Storytelling
Caregivers publicly shared their story of supporting a patient through various media such as television series and interviews, documentaries, podcasts, webinars, videos, presentations, workshops, live storytelling, eulogies, newspaper and magazine articles, blog posts, obituaries, and books: The sole patient participant also shared their story of their illness and desire to access MAiD: 66 Virginia Braun and Victoria Clarke, Thematic Analysis: A Practical Guide to Understanding and Doing (SAGE 2021); Nigel King, 'Doing Template Analysis' in Gillian Symon and Catherine Cassell (eds), Qualitative Organizational Research: Core Methods and Current Challenges (SAGE 2012). 67Jeanneret and others (n 53). 68Braun and Clarke (n 65); King (n 65). 69Jeanneret and others (n 53).
Canadian patients and caregivers as regulatory actors � 313 … I just told them … this is what I've been going through, and I would value this … (2103) Often storytelling had an educative function.For example, one caregiver attended a hospital 'before-rounds' session to inform staff about their family member's experience.Sometimes, storytelling was advocacy oriented.For example, one participant used their family member's experience 'as a point of advocacy' to increase MAiD knowledge; one 'sponsored' a MAiD workshop and invited a local parliamentarian; and one met with a university medical school dean, to get 'more doctors trained in end of life'.These actions overlap with Theme 2 as motivations are inextricably linked to the type of storytelling (educative, advocacy-oriented, or general).

Complaints and feedback
Participants provided feedback to politicians, health professionals, institutions, and funeral homes about suboptimal aspects of MAiD experiences (eg, delays collecting the body post-death, communication around the administration process).One participant, whose family member faced a forced transfer due to an institutional objection to MAiD by a faith-based institution: One participant felt their feedback was being ignored, prompting them to create an online forum to discuss feedback and share information.
Participants also saw participation in this study as providing feedback to contribute to shaping research on MAiD and improving practice.
No one made formal complaints, such as to regulatory colleges, or engaged in litigation, though several participants reported litigation was considered:

Taking on a system role
Some participants had taken on roles within the MAiD system, including as volunteer witnesses with DWDC, in senior roles within DWDC, and with MAiD peer support organisations including DWDC, Bridge C-14, and Bridge4You.One participant (a health professional) became an MAiD provider partly because of delays their family member experienced in arranging MAiD provision: … seeing how it affected my [family member] having to wait … did give me pressure … (2126) Figure 1.The relationship between the four themes, eg, how mediating factors (Theme 4) relate to actions (Theme 1), motivations (Theme 2), and outcomes (Theme 3).It also lists the sub-themes within each theme.
Two other participants (end-of-life doulas) incorporated their lived experience into their work: … it's just amplified the work and the skill that I'm already doing.(2106)

Organisational involvement
One participant attempted to alter an institution's position on forced transfers by becoming a shareholder in the institution objecting to providing MAiD onsite.

Representative and consultancy work
Participants undertook representative and consultancy roles, to represent lived experience as a caregiver of a person who accessed MAiD, in organisations including CAMAP; DWDC's First-Person Advocates' Initiatives Council (for individuals who have supported a person through MAiD); and provincial, national, and international governments.
Participants also attended academic conferences and were involved in research grants as consumer representatives.One participant highlighted the importance of lived experience in academic circles: Another participant worked with an advocacy organisation to develop resources for people preparing to access MAiD, or supporting someone through the process: I'm helping … put together a to-do list and a checklist of things that we've experienced … (2105) On their own initiative, one participant wrote two books on talking to children about MAiD and grief: … that need for something … that's child friendly, just came through so loud and clear … I just felt moved to create these story books.(2106)

Law reform efforts
Several caregivers and patients provided information, wrote letters, wrote briefs to members of parliamentary committees, or appeared in parliamentary proceedings as witnesses.Caregivers and patients were eager to be politically involved.One patient sent an email to every member of Parliament at a federal, provincial, and municipal level.Some participants attended political events or wrote to politicians to provide feedback: No participants reported initiating litigation directed at law reform.

Future activity planned
Some participants planned to engage in future action but were grappling with how and if they wanted to be involved.Some encountered barriers to involvement such as having 'to wait a year before you can be available to consult [in a peer support role]' (2105).

C. Theme 2: motivations for undertaking actions
Participants reported various motivations for undertaking actions in Theme 1, divided into patient-oriented, personal, and system improvement motivations.Often, motivations were multifaceted and spanned across multiple categories.

Patient-oriented motivations
The primary patient-oriented motivation expressed 70  Other family caregiver participants said patients' 'dying request' or expectation was they try to improve the MAiD system; a task they felt privileged to undertake: [Patient] … took my hands and said 'Please don't let me have died for nothing.Make my death have meaning.Tell our story.'(2110)

Personal motivations
Personal motivations included intrinsic personality and values, feelings of obligation, and (for caregivers) processing grief.
Regarding intrinsic personality and values, many participants tried to alter the MAiD system because it had become their 'purpose' or 'mission' or was part of their 'third act' (ie, a period of life focused on contribution).One explained activism is 'just who I am'.Another reflected the MAiD experience had 'found' her and, because it had, she took the opportunity to use the experience productively (as she described, by turning 'lemons into limoncello').
A second motivation was feeling an obligation to act: … if I can be the voice for others … then I feel that's an obligation … (2110) A third motivation was grief, particularly the 'very specific kind of grief' and 'surreal experience' associated with MAiD.Some participants' efforts to influence the system were to process grief with one finding this 'an extremely useful tool in the grieving process'.It also resulted in connections to organisations (such as DWDC, Bridge C-14, or Bridge4You (now referred to as MAID Family Support Society)) which provided opportunities to amplify their efforts.For example, one participant said: … Another participant commented that while many advocates are motivated by altruism, there is an element of advocacy about personal healing because, inherently, advocacy to make something better suggests an aspect of a person's own experience was suboptimal, and advocacy may partially be about reconciling that.

System improvement motivations
Most motivations to improve the system (from participants and/or patients they described) fell into three categories: (i) helping and empowering other caregivers and patients, (ii) filling system gaps, and (iii) changing laws and policies.Often this was intertwined with patient-oriented or personal motivations.For example, some actions directed at bringing about system change were also motivated by honouring a patient.
a. Helping and empowering other caregivers and patients A primary system improvement motivation was helping other caregivers and patients to navigate MAiD. 71This included spreading awareness, destigmatising, educating, and advocating about MAiD as a lawful option: I want to be able to take [patient]'s experience and help others get to that same point, as many as I can … (2120) Participants reported stigma was prevalent after MAiD was legalised, and though things had improved, stigma remains: … I'm currently working with three patients who are struggling to get assessed … you're running up against a lot of different prejudices and stigmas even six years down the road … (2110) Often participants expressed the motivation to help others more generally: … if we've lost someone, we want to help others to go through this process … (2108) Sometimes, it was more specific and linked to a particular means of helping others: It was very clear instantly how fortunate she was to have two people who were honoured to sign … that fuelled me … to register as an independent witness … ( 2113 Many participants recognised a gap in the MAiD system during their MAiD experience, and they wanted to fix it for others, for example, the participant who wrote books about MAiDrelated grief support for children. Another gap was the ability to speak with a peer, leading to individuals offering their support in peer support roles.One participant shared her experience of supporting a family member to access MAiD in a media interview early in the legalisation of MAiD: … I thought 'This would have been so welcome to me when I was at that stage to actually hear from somebody who had been through it … (2114)

c. Change laws and policies
Participants were motivated to change laws and policies.This sentiment is encapsulated in an example provided by a caregiver, who supported a patient through MAiD who had publicly advocated for legal change.The participant explained there was a point during this advocacy when the patient realised her motivation shifted from changing the law for her benefit, because it would happen too late, to improving the law for others: … there was a point where she realised, okay, my advocacy is not about me, my advocacy is about Canadians.( 2121) Another example is a caregiver and patient writing letters to the patient's long-term care facility to try to change the institutional policy prohibiting MAiD onsite: … it was about making a path for people to be able to access this safe, comforting, incredibly helpful medical procedure.It wasn't just about [patient] … (2128) Another family caregiver with legal expertise helped draft guidelines to promote referrals by objecting health professionals.

D. Theme 3: outcomes of actions by caregivers and patients
Actions in Theme 1 had: (i) outcomes for the individual taking the action (self-facing), (ii) outcomes for the system more widely (system-facing), and (iii) no impacts. 72This theme intersects with Theme 2.

Self-facing
The primary self-facing outcomes73 were providing a sense of purpose and/or assisting with grief: The work with Dying With Dignity has been … an extremely useful tool in the grieving process … helping a little bit really feels healing … (2128) … that advocacy … gave purpose again.( 2121)

System-facing
System-facing outcomes can broadly be divided into two categories: (i) impacting MAiD law reform, and (ii) influencing the operation of MAiD in practice.

a. Impacting MAiD law reform
Actions of caregivers and patients impacted law reform and political processes.The most significant example was a patient directly influencing the final consent requirement for all MAiD cases (ie, an exception is now available in some cases).
Several participants influenced law reform by providing personal accounts to members of parliament, impacting parliamentary debates.For example, one participant worked with advocates and lawyers to develop a document sent to parliamentarians about the prohibitive effect of a judicial pre-authorisation requirement (a requirement which was ultimately not included in law).The participant also submitted a document based on her experience supporting her family member, which was cited in parliament: Engagement in representative or consultative roles also meant caregivers and patients had input into decision-making about MAiD practice.
Another outcome was raising MAiD awareness.Sometimes, participants educated healthcare professionals who were unaware MAiD was legal (reported more often by participants with earlier MAiD experiences).One caregiver alerted a doctor to the MAiD coordination team within the hospital.By doing this, participants considered they increased knowledge and awareness among health professionals, which may have impacted their professional practices and their approach to treating other patients seeking MAiD (ie, altered or improved their practice).This also extended to funeral homes, who were provided with feedback.For participants who were health professionals themselves, they described incorporating their lived experience into (thereby improving) their own professional practice.
Not only did participants inform health professionals that MAiD was legal, but they also spread broader MAiD awareness.Outcomes from this were others: (i) thanked them for sharing information and/or (ii) accessed MAiD after becoming aware of the option from stories shared by participants and patients: … since I told … our story, people come to me for information … I've been personally involved in another four, I've actually provided information for many more … (2114) The culmination of outcomes outlined above contributed to normalisation of MAiD and integration into end-of-life care.

No impact
Some caregivers and patients indicated their actions did not change MAiD law or its operation in practice.One participant indicated that a challenge to an institutional policy requiring a forced transfer was unsuccessful: Unfortunately, I don't think that they're going to respond to heartfelt pleas or goosebumpinducing writing or even threats of legal action … The only thing that will make that difference is legislative … (2128)

E. Theme 4: mediating factors
A range of intrinsic and extrinsic factors mediated participants' and patients' ability to take actions to alter the MAiD system (Theme 1).These factors also affected a person's motivations (Theme 2) and whether they could achieve the outcome they sought (Theme 3).

Intrinsic mediating factors
One intrinsic mediating factor facilitating action was the individual's personality and attitude towards MAiD.A key aspect was supportiveness of MAiD: all participants were in principle supportive of MAiD and of their family members' choice to access MAiD, though some experienced reservations or complexities within their experience.This factor overlaps with Theme 2 but is reported here because it affects whether they would undertake actions, and what kind (Theme 1).For example, participants were motivated to volunteer as MAiD witnesses because of their support for MAiD in principle. 74ther aspects of personality and attitudes towards MAiD also facilitated action: it was in their 'nature', or they were just 'that kind of guy', with one participant referring to themselves as an 'activist'.Another said: I'm as outspoken as my mother … it's part of the reason that I've contacted Dying With Dignity … (2129) Conversely, an intrinsic mediating factor that was a barrier to action was health status.This was exemplified by one participant who described the patient declining to litigate saying 'I'm too tired' (due to the progression of her illness on her health).
When a patient was too unwell to act, they engaged others to assist.One participant described the patient engaging their assistance with their advocacy ambitions: the patient advocated for law reform and realised they would not be able to see the results of this advocacy due to illness progression, so said to the participant: 'This is what you've got to do … you're going to fight for this' (2121).

Extrinsic mediating factors
One extrinsic mediating factor that was both a facilitator and a barrier was the nature of a person's experience, including whether they experienced roadblocks or gaps (ie, facing a barrier such as institutional objection, or lacking support).
The nature of a person's MAiD experience sometimes facilitated action, and affected the type of action they took (linked to Theme 2).Often, a person's actions were directed at overcoming similar roadblocks or filling system gaps they experienced.A clear example is participants joining peer support organisations or sharing stories because this would have been 'welcomed' during their own experience.Another example is the participant who wrote books on grief because those resources were absent for them.System maturity at the time of the person's MAiD experience was also relevant, with some commenting they acted because the system was so new.
In some instances, however, a difficult MAiD experience was a barrier.For example, one participant was emotionally drained by the difficult MAiD process (caused by the long-term care facility's stance on MAiD and obstructive behaviour) and felt like they could not engage as their energy was expended supporting the patient's choice for MAiD: I really grappled with actually giving some pretty serious feedback … But … you're emotionally drained … in the end you decide to just let it go.(2112) A second extrinsic factor facilitating action was connections to advocacy groups,75 highprofile individuals, media, or research teams.
In relation to advocacy groups, many participants specifically mentioned a relationship with DWDC, or high-profile individuals within DWDC, including one participant previously holding a senior position with DWDC.This connection facilitated actions or amplified outcomes because of DWDC's reach and status as a national organisation.
In contrast, the absence of DWDC in their region prompted one participant to act: … we're very disconnected from the Ontario headquarters … we have our own little world out here.( 2103) Connections to other high-profile individuals or organisations external to DWDC also facilitated actions.For example, one participant said: … one of our members of Parliament is a personal friend and she wanted to know [patient]'s story and she presented [patient]'s story … ( 2104) Other high-profile individuals and organisations mentioned included key legal academics, the British Columbia Civil Liberties Association (BCCLA), CAMAP, Bridge C-14, Bridge4You (now known as MAID Family Support Society), religious leaders, university professors, care coordinators, and other individuals such as MAiD advocates or persons with lived experience.Media attention also had a significant facilitating impact and provided opportunities to undertake action, such as podcasts, television interviews, and newspaper articles.It also amplified the voices of patients and participants by increasing the reach of actions, making it more likely they could achieve their desired outcome (Theme 3): … the media got involved and the newspaper in [location] devoted the whole front page … everywhere I went people would stop and thank me … for having had the courage to be so public … (2110) And finally, some participants were involved in research teams and on research grants which facilitated action: … the researchers wanted to include us and our perspective … they really value that … (2113)

A. Overview of findings
Caregivers and patients engaged in actions, including storytelling, making complaints, providing feedback, and law reform-oriented actions, that can be defined as 'regulatory' according to Black. 76 They were motivated to act by factors including wanting to help others, filling system gaps, or changing laws or policies.Participants perceived their actions (i) impacted Canadian MAiD law reform and (ii) influenced the implementation, delivery and functioning of MAiD in Canada (ie, the operation of MAiD in practice).Sometimes, though, actions had no outcome and participants perceived stronger forms of regulation (eg, laws) were necessary to achieve change.
The range of regulatory actions reported by participants was broad.Regulatory actions were directed towards law reform or to the operation of MAiD in practice.By directed towards 'law reform', we mean that some regulatory actions were directed at changing the law to allow MAiD or, post-legalisation, to overcome perceived legal barriers by changing the law (eg, the final consent requirement).Other regulatory actions were not directed at changing the law, but rather at the operation of MAiD in practice within the existing legal 76 Black (n 9).framework.This included overcoming barriers to access in practice (eg, volunteering as an independent witness) or filling gaps in regulation (eg, creating resources).While some categories of actions described in Theme 1 were directed at just one of these aims, eg, the action we have described as 'law reform efforts' is solely directed at altering law reform, most actions could be directed at either depending on the circumstances.For example, 'storytelling' could be educative and aimed at spreading awareness about MAiD to make the option of MAiD more accessible (directed at altering the operation of MAiD in practice), but it could also be advocacy-oriented storytelling directed at drawing attention to a legal barrier, which could only be resolved through law reform.Table 4 highlights the relationship between examples of regulatory actions (Theme 1) undertaken by patients and families, how they link to aspects of the MAiD process, and how these actions relate to either impacting law reform or influencing the operation of MAiD in practice (Theme 3).

B. Caregivers and patients can be regulatory actors
Individuals have been influencing MAiD law reform in Canada for some time.Caregivers and patients have impacted law reform through litigation and advocacy which resulted in MAiD being legalised, 77 and clarified by courts, 78 and further Criminal Code amendments through Bill C-7. 79Advocacy directed at law reform which successfully changed the final consent requirement, and successful advocacy to prevent a judicial pre-authorisation requirement being included in Bill C-14, 80 were also reported in this study.
Our results demonstrate caregivers and patients have altered how Canadian MAiD systems operate in practice, beyond law reform, too.This includes impacting practice by taking action to fill gaps in regulation or to address system issues.Our findings are consistent with studies suggesting Canadian caregivers and patients are active participants in MAiD decision-making and care, 81 and allies in quality improvement, 82 and medical education. 83owever, our findings are novel in that they map the broad range of inventive and creative actions to alter behaviour, and the significant outcomes of those actions.Our findings also highlight that caregivers and patients are part of broader 'networks' 84 involving advocacy organisations, religious leaders, key academics, members of parliament, and each other, seeking to alter the MAiD system.Applying Black's definition of sustained and focused action (element 1), directed towards altering others' behaviour (element 2), with an intention to produce a particular outcome (element 3), some caregivers and patients are regulatory actors in Canada's MAiD system.A clear example is that one participant, among other things, wrote a book, created a community group to share feedback, undertook representative or consultancy roles with organisations and governments, and attended academic research conferences.This variety of actions over time indicates 'sustained and focused action' (element 1), directed at altering behaviour of others, including by improving their practice through feedback or input into decisionmaking (element 2).The participant expressed motivations such as increasing patient and family voices in MAiD practice, helping others, and improving the system, demonstrating an intention to produce particular outcomes (thus also meeting the third element of Black's definition).The actions of this participant which sought to influence the operation of MAiD in practice are regulatory, irrespective of their outcome, as outcome is not an element of Black's definition.
Another clear example is a participant who wrote children's books about grief and MAiD, who has also been involved in advising on a MAiD clinical curriculum (ie, sustained and focused action to alter behaviour, elements 1 and 2) with a motivation to help others and improve the system by altering behaviour (element 3).These actions were directed at influencing the operation of MAiD in practice.Finally, one participant spoke of tenacious, coordinated, and intentional advocacy efforts over a period of time (sustained and focused action, element 1) to change the final consent requirement (directed at altering behaviour and intended to change the law, elements 2 and 3), resulting in an exception to that requirement being introduced by Bill C-7.These actions were directed at influencing law reform.These are just three examples from the data which clearly demonstrate that some caregivers and patients behave as, and can be construed as, regulatory actors by taking action to influence law reform and/or the operation of MAiD in practice.However, not all caregivers and patients in this study, or generally, are regulatory actors.For example, a person who tells the story of their experience to process their grief, and who takes no further action, may not be a regulatory actor as this action is not sustained or focused action directed at altering behaviour (though we note that there are different definitions of regulation, 85 and if a different definition of regulation were adopted this may be considered regulatory).A person's status as a regulatory actor is not static and may change over time.For example, a person who undertakes sustained, focused, and intentional action and then achieves their goal may step back and cease to act in regulatory ways.While not all caregivers and patients are regulatory actors, our findings suggest some caregivers and patients are capable of being construed as regulatory actors, and therefore caregivers and patients should be included in discussions of who and what impacts MAiD regulation (both in terms of law reform and the operation of MAiD in practice) in Canada.
Regulatory actions reported in this study were focused on supporting access to MAiD, but regulatory actors may also seek to advance other outcomes.This study sought to explore the experiences of persons who had accessed MAiD (primarily via reports of family caregivers) or were in the process of accessing MAiD.Our participants were all supportive of MAiD in principle and although there was diversity in experiences, family caregivers all supported their family member's decision (as discussed further in the strengths and limitations section).Yet, some reports suggest family members who are ambivalent or opposed to MAiD or who do not support their family member's decision may also take action to alter law reform or the operation of MAiD in practice in ways that may seek to limit access or add further safeguards. 86While these experiences did not arise in our sample, our findings could be applied more broadly to understand what actions (eg, storytelling) those opposed to MAiD may take to shape the MAiD system (in terms of both law reform and the operation of MAiD in practice).They may also help to understand why actions may not achieve their intended outcomes (eg, a lack of connection to advocacy groups or high-profile individuals).

C. Patient and family caregiver regulatory action improves MAiD quality in Canada
Patients' and caregivers' regulatory actions impacted the functioning and operation of MAiD in practice in ways they perceived improved the system.Their actions targeted aspects of MAiD systems identified in Canadian literature that participants perceived as barriers to quality MAiD care (see also Table 4). 87This suggests caregivers and patients have stepped up to fill system gaps or problems in the functioning of MAiD regulation, as well as illuminating aspects of MAiD that were a problem so that these gaps and problems could be addressed by others.Through their sustained, focused, and intentional actions (ie, regulatory actions, according to Black), caregivers and patients have also contributed to what Pesut and others describe as the 'cultural calibration' of MAiD (ie, the calibration of systems to meet the needs of caregivers and patients, with participants in the MAiD system adjusting themselves to those demands). 88Participants and patients in our study actively altered the system to meet their needs, and those of other caregivers and patients, as part of this 'cultural calibration'.We highlight three examples of barriers identified in Canadian literature, 89 and how actions of participants sought to address these barriers to improve MAiD care and 'calibrate' the system.
The first barrier is lack of awareness of MAiD and process clarity. 90Most participants took actions (eg, storytelling) to spread awareness and educate others about MAiD and destigmatise and normalise it as an end-of-life choice; actions which may contribute to influencing how MAiD is operating in practice.This occurred within personal networks, workplaces, and more widely via advocacy organisations or media platforms.Participants perceived these actions increased MAiD awareness amongst health professionals and wider communities.Several participants also helped to develop (or improve the clarity of) MAiD resources, including through representative and consultancy work.
A second barrier is unduly burdensome legal requirements (eg, independent witnessing requirements, 91 and the final consent requirement for all MAiD cases). 92Many participants became volunteer witnesses, motivated by a desire to reduce burdens on individuals seeking MAiD (and their families) to locate witnesses.Other participants (successfully) advocated to change the final consent requirement, resulting in an exception to the requirement being available in some cases (Table 1).Action by caregivers and patients to overcome what they perceived as unduly burdensome legal requirements was directed both at changing the law and at the operation of MAiD in practice (by trying to reduce the impacts of those legal requirements in the everyday practice of MAiD).
A third barrier is the impact of objections by clinicians and institutions to MAiD on patients' and caregivers' experiences. 93One participant helped develop policy guidelines about referral requirements for objecting clinicians.Another, along with the patient and BCCLA, wrote letters to a long-term care facility to persuade them (unsuccessfully) to change their position on forcibly transferring the patient away for MAiD provision.Both are examples of attempts to influence the operation of MAiD in practice.Close and others' paper on institutional objection found patient and caregiver advocacy, particularly when amplified by the media, was a catalyst for change in institutional approaches towards MAiD and sometimes contributed to institutions allowing assessments onsite. 94Wiebe, in an article by Gerson and others, has also commented that patients have led change in shifting attitudes of palliative care providers towards acceptance and integration of MAiD. 95 Canadian patients and caregivers as regulatory actors � 331 Australia and Canada, empirical studies found top-down regulatory responses may be needed to address institutional objections, particularly in faith-based settings. 96This resonates with our findings: some facilities may not respond to actions by caregivers and patients or respond to a limited extent, meaning other kinds of regulatory responses (eg, law reform efforts directed at introducing legislation or litigation) are necessary.D. MAiD system should be responsive to action to improve quality of MAiD regulation Using a broad, polycentric conceptualisation of 'regulation' to understand the ways in which caregivers and patients impact law reform and the operation of MAiD in practice in Canada is important.It provides language to describe and identify the phenomenon, and helps to see how others are shaping the system beyond government and formal regulators.Black's definition of regulation applied in this study requires sustained, intentional, and focused action to alter behaviour to achieve a particular outcome.This means that some caregivers and patients are going beyond a once-off action and taking repeated action directed at changing MAiD in Canada.
'Regulatory action' as we have defined it may be difficult for caregivers and patients to undertake, 97 and it should not be expected of them.Some individuals may prefer not to participate in this way, a consideration which is sometimes overlooked in literature advocating for greater patient and caregiver involvement in decision-making. 98Additionally, they may lack power to act in regulatory ways because of systemic disadvantage, isolation, or other vulnerabilities, which are compounded by existing inherent power imbalances between caregivers and patients and other regulatory actors, like health professionals, 99 or health institutions.This is particularly pertinent in the MAiD context, where patients, by definition, have a grievous and irremediable medical condition causing intolerable suffering.Regulatory action may be particularly burdensome when resulting from a negative experience, such as encountering a barrier to MAiD access.As key motivations of participants were helping others, filling system gaps, and changing law and policy, this suggests there are deficiencies in MAiD regulation which are (at least partially) falling to caregivers and patients to be identified, remedied or overcome (or where this is not possible, the patient may miss out on their choice of MAiD).One participant in this study explicitly raised that sometimes actions are motivated by having a traumatic experience.This resonates with research in other contexts, which has found that a key reason why individuals who experience adverse events in healthcare make complaints is to prevent other individuals from experiencing the same kind of adverse event or highlight systemic problems. 100It also aligns with literature that suggests that family members can have a broad range of experiences and feelings about their involvement in MAiD. 101For example, Crumley and others' recent study describes some participants who experienced the 'nuances of guilt from participating and trauma from witnessing a relative's death, especially if it was accelerated'. 102otwithstanding this, there are significant benefits to involving caregivers and patients in regulation, including improving laws (law reform) and healthcare systems (operation in practice). 103Caregivers and patients should be supported to undertake regulatory action if they wish to. 104For many caregivers and patients in this study, regulatory action was a meaningful, fulfilling, and rewarding undertaking.Akin to health professionals who describe MAiD work as rewarding and satisfying, 105 many caregivers and patients reported that their role in influencing MAiD regulation afforded them a sense of purpose.When caregivers and patients are acting in regulatory ways, particularly when this action is meaningful to them, this action should be supported.A well-functioning regulatory system is responsive to patients' and families' concerns and actions. 106Regulatory systems should listen to and, where appropriate, act to investigate and address concerns raised by patients and families (including concerns about the appropriate balance between safeguards and access), who have expertise as the users of MAiD systems.As Braithwaite aptly states: As new players come on to the field and create opportunities to build new strengths and be tripped up by new problems, smart regulators assemble the particular set of players capable of grasping contextually attuned strategies to the emerging problems and opportunities. 107 the MAiD context, caregivers and patients have demonstrated they should be part of the 'assembled set' of capable regulatory players, 108 where they choose to be.

E. Strengths and limitations
This is the first known study to use a regulatory lens to examine how caregivers and patients behave as regulatory actors and participate in Canadian MAiD regulation.
We collected data from caregivers across three diverse provinces, with experiences spanning six years of MAiD in Canada.This study primarily reports on caregivers' perspectives and their accounts of patients' experiences; we were only able to recruit one patient, as this is a difficult cohort to recruit.A limitation of the research is that caregivers' perceptions may differ from the patient they were supporting.Their perceptions may be affected by factors such as grief and bereavement. 109However, evidence suggests caregivers can be reliable third-party reporters, particularly for considering the quality of end-of-life care and observable symptoms. 110Further research directly with patients, or with persons who are not the patient's primary support person, may provide additional or different insights.Additionally, as existing research on the use of third-party reporters has not examined MAiD, further research on the use of third-party reporters' accounts in this context is needed.
This study is also primarily focused on the experiences of persons with a reasonably foreseeable natural death who accessed MAiD in British Columbia, Ontario, and Nova Scotia; only one participant had a Track 2 experience.Further research with persons whose natural death is not reasonably foreseeable, as well as research with diverse experiences (eg, ineligible patients, those who missed out, diverse demographic backgrounds, and in other provinces/territories) is needed.Canadian patients and caregivers as regulatory actors � 333 Our participants all supported MAiD in principle and all family caregiver participants supported their family member's decision to access MAiD, though there was diversity in experiences.Additionally, since one form of recruitment was having the study advertisement distributed by advocacy organisations that support MAiD, some participants had direct connections to these groups.Further research with individuals who are unsupportive or ambivalent about MAiD, and with those who did not support their family member's choice to pursue MAiD, would provide insight into their views and how they influence regulation.These individuals may also be characterised as regulatory actors and research with such individuals may result in different findings about actions, motivations, outcomes, and mediating factors.
Given our qualitative research design, our findings are not intended to be generalisable.

V. CONCLUSION
This article challenges the framing of caregivers and patients as solely being objects of regulation in Canada's MAiD system.Caregivers and patients should be recognised as actors with voice and agency who alter regulation, including influencing law reform and operation of MAiD in practice in Canada.For many caregivers and patients, action was meaningful and rewarding, which is positive and should be supported.Canadian MAiD regulators (and those in international jurisdictions) should be responsive to their experiences, perspectives, and their actions (regulatory or otherwise).However, the burden of taking regulatory action to address barriers to access or to quality MAiD care, or MAiD system gaps, should not fall to caregivers and patients, particularly those who do not want to regulate (or who cannot, and therefore, miss out on their choice of MAiD).Where regulatory action by caregivers and patients is necessitated by experiences of barriers to access or to quality care, or MAiD system gaps, this should signal to other regulators that consideration should be given as to how those barriers or gaps could be resolved by other regulatory means.Jurisdictions that are early in the implementation of MAiD should consider how to involve caregivers and patients to refine and improve regulation where they wish to be involved.So too should jurisdictions consider implementing MAiD in future: patient and caregiver involvement would be beneficial from the outset to ensure that MAiD practice is patient-and family/ caregiver-centred.

…
worked with the BCCLA [British Columbia Civil Liberties Association] … The rabbi of the synagogue wrote a letter.I wrote a letter.[The patient] wrote a letter.(2128) ) … I thought it [storytelling] might help other immigrant families of colour and Muslims.None of these things are mutually exclusive from you being able to have an assisted death … (2102) b.Filling system gaps

I
'm … listening to this, like oh my gosh, she's talking about my [family member] … The vote comes back in, and it's defeated.(2102) b.Influencing the operation of MAiD in practice Actions of patients and families influenced the functioning and operation of MAiD in practice.Participants perceived their actions improved accessibility.For example, many participants volunteered as witnesses, with one having done 'about 25'.Participants in representative or consultative roles helped to improve resources by increasing readability: … I said 'If you're an immigrant … if you're an Aboriginal person living in a remote area … , can you access that information, do you understand it … ?… ' They … rewrote it in accessible language … (2110)

Table 1 .
Key aspects of MAiD lawCourt declared the reasonably foreseeable requirement in the Criminal Code (and the endof-life requirement in the Quebec legislation) unconstitutional.31Responding to Truchon, Bill C-7 removed the natural death has become reasonably foreseeable eligibility criterion (it remains the characteristic determining which procedural safeguards apply), with effect from March 2021.32Thismeans that individuals whose natural death is not reasonably foreseeable are now able to apply for and access MAiD under the 'Track 2' procedural safeguards (Table a Bill C-14, An Act to Amend the Criminal Code and to Make Related Amendments to Other Acts (Medical Assistance in Dying), SC 2016, c 3. b Bill C-7, An Act to Amend the Criminal Code (Medical Assistance in Dying), SC 2021, c 2.

Table 2 .
Characteristics of interview participants (n ¼ 34) a One participant reported two cases, so this category is calculated using the total number of relationships (n ¼ 35).

Table 3 .
Characteristics of patients described by interview participants (n ¼ 33) The participants who reported on patient cases relating to other provinces were either located in one of the target provinces, or also reported on a patient case that occurred in one of the target provinces, hence inclusion in our sample.This patient was transferred from a long-term care facility on the day of MAiD administration.Canadian patients and caregivers as regulatory actors � 315 … it was clear … we could go to court … And she [patient] looked at me and she said, 'I'm too tired,' and there were tears in her eyes.(2128) a Two patients died in hospital but not from a MAiD death.b One patient died in the long-term care facility but not from a MAiD death.c We live it.Instead of telling us what you think we need, why don't you ask us not only what we need but what we want?(2110) 6. Resource development Related to representative and consultancy roles was resource development.For example, two participants advised on a new clinician MAiD curriculum.
Canadian patients and caregivers as regulatory actors � 317One participant described concerted efforts (including media efforts and direct contact with legislators) by a patient, supported by caregivers and DWDC, to change the final consent requirement.The patient knew law reform efforts would not succeed in time for them to benefit, so asked the participant (and others) to continue advocating after their death: … I showed up [at a political event] and I chatted with [Minister] … I was very much against her restrictions in Bill C-14 … (2103) … 'This is what you've got to do … you're going to fight for this.' (2121) if [patient]'s leaving us too soon can in some way help others, I am so open to sharing his story, partly because yes, it's healing for me … (2107)

Table 4 .
Relationship between regulatory actions, outcomes, and aspects of the MAiD process

Table 4 .
(continued) troduced changes to these laws (Table 1) but because our sample reports on experiences from 2016 to 2022, this is relevant in answering our research question.Qualitative Study of Experiences of Institutional Objection to Medical Assistance in Dying in Canada: Ongoing Challenges and Catalysts for Change' 24 BMC Medical Ethics 71.